Limited access suturing devices, system, and methods

ABSTRACT

Medical suturing devices, systems, and methods will be useful for endoscopic (with or without access ports) or other surgeries in which access is limited, including ear, nose, and throat procedures. Articulation motions may be transferred from a handle to needle grasping jaws using an axial movement of a shaft that has axial stiffness (such as being stiff in compression) and lateral flexibility or an axial movement of a cable. An extension body (within which the shaft or cable moves) between the handle and jaws can be pre-bent or custom bent by the user. Portions of the devices may be disposable, replaceable, and/or reusable. A spring adjacent the clamp may open the clamp or impose a gripping force.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of priority from U.S. ProvisionalPatent Application No. 60/895,058, filed on Mar. 15, 2007 and entitled“Suturing Device, System, and Method” (Attorney Docket No.025945-000120US), the full disclosure of which is incorporated herein byreference.

The subject matter of this application is related to that of applicationSer. No. ______, filed concurrently herewith and entitled “ReplaceableTip Suturing Devices, Systems, and Method for Use with Differing Needles(Attorney Docket No. 025945-000200US); and to that of application Ser.No. 11/532,032, filed Sep. 14, 2006 and entitled “Suturing Device,System, and Method” (Attorney Docket No. 025945-000110US); which is acontinuation-in-part of U.S. patent application Ser. No. 11/227,981filed Sep. 14, 2005, the full disclosures which are all incorporatedherein by reference.

BACKGROUND OF THE INVENTION

The present invention generally relates to medical devices, systems, andmethods. In specific embodiments, the invention provides devices,systems, and methods for suturing tissues in open surgery, minimallyinvasive surgical procedures, and the like.

Although many aspects of surgery have changed radically over the lastseveral decades, some surgical techniques have remained remarkablyconstant. For example, as was true fifty years ago, suturing remains acommon technique for approximation of tissues, ligation of tissues,affixing tissues together, and the like.

Suture has been used in open surgical procedures for generations totherapeutically treat diseased tissue and to close surgical access sitesand other wounds. More recently, the use of minimally invasive surgicaltechniques has expanded, with surgical therapies often being performedat internal surgical sites. Although a wide variety of visualizationtechniques (including laparoscopes and other endoscopic viewing devices,fluoroscopy and other remote imaging modalities, and the like) have beendeveloped to allow surgeons to view these internal surgical sites, andalthough a large variety of new tissue treatment techniques have beendeveloped (including ultrasound techniques, electrosurgical techniques,cryosurgical techniques, and the like) and are now widely available,many modern surgical interventions continue to rely on suturing.

A wide variety of alternatives to suturing of tissues have beendeveloped, and have gained varying degrees of acceptance in certainsurgical procedures. Staples and tissue adhesives are used quitefrequently in many open and minimally invasive surgical settings, and avariety of tissue welding techniques have also been proposed.Nonetheless, suturing remains ubiquitous in surgery, as suturingprovides a number of advantages over many of the alternatives.

Suture's advantages include the large knowledge and skill base thatsurgeons have developed over the years. Additionally, a variety ofoff-the-shelf, pre-packaged surgical needles with suture are availablefrom a large number of suppliers at very reasonable cost. Surgeons areable to precisely control the location of suture stitches by graspingthe suture needle and first pushing it and then pulling it through thetarget tissue. In open surgery the surgeon may manually grasp the sutureneedle directly with his or her hand, although both open and minimallyinvasive procedures are often performed by grasping the needle with aneedle grasping tool and manipulating the tool to place the suturestitches. The results obtained using suture are highly predictable,although dependent on the skill of the surgeon. In light of itsadvantages, the use of suture does not appear likely to disappear anytime soon, with even modern robotic surgical techniques often making useof suture.

Although suture remains popular in surgery at least in part due to itssignificant advantages, suturing is not without disadvantages. Inparticular, placing a large number of suture stitches can be tiring andquite time-consuming. Manipulation of a suture needle can be difficulteven in open surgery due to the limited space that is often availablearound the target tissues. The challenges of manipulating suture needlesmay be even greater in minimally invasive surgical procedures, where theneedles are often manipulated using long-handled tools extending througha small aperture, typically while viewing the procedure on a displaywhich is offset from the surgical site. Tying knots with a desiredamount of tension and the like may call for intricate and precisemanipulation of the suture, further complicating and delaying open andminimally-invasive surgeries. In fact, the time spent closing/suturingthe access site may be significantly greater than the time spenttreating the underlying target tissues for many procedures.

There have been a variety of proposals for modifications to standardsurgical suturing structures and methods to try to address the abovedisadvantages. At least some of these proposals may seek to rely onspecialized and/or proprietary suturing needle systems, which couldincrease costs and preclude their wide acceptance, especially in thirdworld countries. Unfortunately, many proposals for modifying existingsuturing techniques may also decrease the surgeon's control over theplacement of the suture, such as by relying on an automated or indirectmechanical movement of a device to drive a suture needle into and/orthrough tissues. While these new proposals have in the past or may inthe future gain varying degrees of acceptance in one or more surgicalprocedures, standard suturing techniques continue to predominatethroughout surgery in general.

In light of the above, it would be desirable to provide improvedsuturing devices, systems, and methods. It would be generally desirableto maintain some, most, or all of the advantages of standard suturingtechniques, preferably while decreasing the time required for suturing,the strain on the surgeon, the training involved in achieving competenceor time-efficiency in suturing techniques, or the like. It would beparticularly advantageous if these improvements could be providedwithout requiring extensive capital investments for new equipment,without significant increases in complexity of the suturing process, orwithout having to resort to specialized or proprietary suturing needlesand the like. Alternative needle grasper structures which increased theease and accuracy of stitching, and/or which are readily adapted for avariety of different procedures and patient physiologies would also bedesirable.

BRIEF SUMMARY OF THE INVENTION

The present invention generally provides improved medical suturingdevices, systems, and methods. Embodiments of the invention provideimproved suturing systems, devices and methods that maintain some or allof the advantages of standard open and/or minimally invasive suturingtechniques while providing enhanced speed and ease of use. While someembodiments will find uses in a wide range of open surgical procedures,many advantageous embodiments will be particularly useful for minimallyor less invasive surgeries, otolaryngology, pediatric surgeries,endoscopic surgeries (with or without trocar access), laparoscopicsurgeries, and/or other procedures in which access to a suture site islimited. Articulation motions may be transferred from a handle to needlegrasping jaws using an axial movement of a shaft or cable that is incompression or tensions and lateral flexibility. An extension body(within which the shaft or cable moves) between the handle and jawstwill often be pre-bent or custom bent by the user for a particularsurgery. Portions of the devices may be disposable, replaceable, and/orreusable, with different needle-grasping jaws and/or different elongateextension bodies having different configurations often being selectablycoupleably to an articulatable handle and housing so as to allow theuser to configure the device for a particular procedure.

In a first aspect, the invention provides a suturing device for use witha suturing needle. The device comprises a body having a proximal end anda distal end, the body including an elongate extension extending alongan axis toward the distal end. The extension is configured to define abend in the axis, and a first clamp is disposed near the distal end ofthe body. A linkage is configured to effect a movement of the firstclamp between a grasping configuration and a released configuration,allowing the first clamp to grasp the needle in the graspingconfiguration and release the needle in the released configuration. Thelinkage comprises a shaft movable along the axis within the extension soas to effect the movement of the clamp. The shaft has axial stiffnessand is laterally flexible so as to transmit the movement and accommodatethe bend.

Optionally, the extension comprises a plastically deformable tubularbody sufficiently stiff to allow support the needle relative to theproximal end, and sufficiently deformable to allow manual imposition ofthe bend, preferably without collapsing or kinking of a tubular openingin the extension that receives the shaft. Alternative embodiments may bepre-bent. In one exemplary embodiment, the shaft comprises a series ofshaft elements with joints therebetween so as to transmit compressivemovement and accommodate propagation of the bend relative to the shaftas the shaft moves axially within the extension. The shaft elements may,for example, comprise spherical bodies, with the joints comprisingindentations in the spherical bodies to slidingly receive an adjacentspherical body. Alternative embodiments may make use of flexible tensionmembers such as a cable or the like to transmit movement across the bendof the extension.

The first clamp may comprises first and second jaw elements, each havingneedle grasping surfaces, wherein each jaw element has a slide surfacefor slidably engaging a wedge surface of the linkage. Axial movement ofthe shaft within the tubular body can thereby effect sliding movement ofthe wedge along the slide surfaces of the jaws so as articulate theclamp. In some embodiments, axial movement of the wedge in a first axialdirection forces the clamp toward a closed configuration, while axialmovement of the wedge in a second axial direction allows a spring tourge the clamp open with a spring-imposed jaw opening force.

At least a portion of the extension, at least a portion of a shaft ofthe linkage movable axially within the extension to articulate theclamp, and/or the clamps are releasably coupled to a proximal portion ofthe device as a quickly replaceable clamp unit. A plurality ofalternative releasably attachable clamp units may also be provided, thevarious clamp units, when mounted to the proximal portion, definingdifferent bend angles, extension lengths, clamping forces, needle sizes,and/or clamp types. The clamp unit may comprises one or more polymer,and the needle grasping surfaces of the clamp unit may comprise a metalso that the clamp unit is disposable. In other embodiments, the clampunit comprises metal and is configured to withstand repeatedsterilization.

In another aspect, the invention provides a suturing device for use witha suturing needle. The device comprises a body having a proximal end anda distal end. An extension is extendable along an axis distally of thebody. The extension is configured to define a bend in the axis. A firstclamp is supportable near the distal end of the extension, and a linkagemoves or reconfigures the first clamp between a grasping configurationand a released configuration. The first clamp is configured for graspingthe needle in the grasping configuration and the first clamp isconfigured to release the needle in the released configuration. Thelinkage comprises an elongate member movable along the axis of theextension so as to effect the movement of the first clamp. The member islaterally flexible and axially inelastic so as to accommodate the bendwhile transmitting the movement.

In embodiments having bends of more that 10 degrees, and particularlywhen the bend is more than 20 degrees, the member may comprise a seriesof elements with joints therebetween so as to transmit compressivemovement and accommodate propagation of the bend relative to the memberas the member moves axially within the extension. When small bends,often having bend angles of less than 30 degrees or even less than 15degrees will be used, the member may instead comprise a flexible tensionmember such as a cable, filament, ribbon, or the like. The clamp oftencomprises first and second jaws elements having needle graspingsurfaces, and each jaw can have a slide surface for slidably engaging awedge surface of the linkage. Axial movement of the member within thetubular body of the extension effects sliding movement of the wedgealong the slide surfaces of the jaws so as to articulate the clamp.Axial movement of the wedge in a first axial direction may force theclamp toward the open or closed configurations, and axial movement ofthe wedge in a second axial direction may allow a spring to urge theclamp toward the other configuration using a spring-imposed clamparticulation force. The spring force may be used to grip the needle, sothat the clamp maintains the gripping force unless and until the linkagereleases the needle.

Advantageously, the extension can have an outer surface suitable forinsertion into a minimally invasive surgical site, optionally through anaccess port while maintaining insufflation, through a natural orifice ofthe body such as the mouth, through a subxiphoid incision ormini-thoracotomy, or the like. In such embodiments, movement of themember generally occurs within the outer surface of the extension sothat the outer surface of the extension does not increase in profileduring suturing.

In some embodiments, the clamp has one or more gripping surfaces thatmove axially so as to grasp the needle axially while a needle axisextends between the gripping surfaces. In other embodiments, at leastone gripping surface moves laterally so as to grasp the needle laterallywhile a needle axis extends between the gripping surfaces. One or bothinterfaces at the ends of the extension may accommodate manual rotationabout the axis so as to alter an orientation of the bend relative to thebody, and/or of the clamp relative to the extension.

In another aspect, the invention provides a suturing device for use witha suturing needle. The device comprises a body having a proximal end anda distal end. An extension is extendable along an axis distally of thebody, and the extension is configured to define a bend in the axis(typically either by being pre-bent, or by being plastically bendable).A first clamp is supportable near the distal end of the extension, and alinkage effects a movement of the first clamp between a graspingconfiguration and a released configuration. The first clamp isconfigured for grasping the needle in the grasping configuration, andfor releasing the needle in the released configuration. The linkagecomprises an elongate member movable along the axis of the extension soas to effect the movement of the first clamp. The member is laterallyflexible so as to accommodate the bend while transmitting the movement,the member typically comprising a flexible tension member or the like.

In a method aspect, the invention provides a suturing method comprisinggrasping a needle with a clamp. The clamp is supported by an extension,and the extension has an axis with a bend. The needle is inserted into atissue region by moving a body supporting the extension so that theneedle moves in correlation with the body. The clamp is articulated bymoving a laterally flexible member axially relative to the extension,the member being axially inelastic. Typically, a distal end of theneedle is inserted through the tissue by moving the needle in rigidcorrelation with the body. Similarly, the needle may be pulled free fromthe tissue by moving the needle in rigid correlation with the body.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an exemplary embodiment of a suturingdevice with one of the clamps of the suturing device grasping a suturingneedle.

FIG. 2 is a perspective view of a proximal portion of the suturingdevice of FIG. 1, with a cover removed from a proximal housing of thesuturing device to show a portion of a linkage coupling a handle of thesuturing device to the clamps of the suturing device.

FIG. 3 is an exploded perspective view of components of the linkageshown in FIG. 2.

FIG. 4 is an exploded view of a distal portion of the suturing device ofFIG. 1, showing components of a clamp along with a reciprocatable shaftand elements of the linkage that effect movement of the reciprocatableshaft and actuation of the clamp.

FIGS. 5-9 are perspective views showing use of the device of FIG. 1 forsuturing tissues.

FIG. 10 is a perspective view of an alternative suturing device havingfirst and second clamps which both reciprocate and rotate away from asuturing needle after releasing of the needle from the clamp.

FIGS. 11A and 11B illustrate an exemplary suturing device in which theclamps arc releasably coupled to the body of the device, allowing theclamps to be disposable to avoid cross contamination between differingpatients without having to sterilize the clamp structures.

FIGS. 12A and 12B are a side view and top cross-sectional view,respectively, of another embodiment of a suturing device having a drivelinkage with an alternatable drive element for moving first one clampand then the other, and also having an alternatable latch for inhibitingmovement of the clamp that is not being driven.

FIG. 13 is an exploded view schematically showing some of the componentsof the drive linkage of the suturing device of FIGS. 12A and 12B.

FIGS. 13A-13M arc cross-sectional views schematically illustratingactuation of the linkage of the suturing device of FIGS. 12A and 12B.

FIGS. 14A-14C are perspective views of a distal portion of analternative suturing mechanism in which axially offset clampsalternately grasp proximal and distal portions of a ski jump suturingneedle.

FIG. 15 is a perspective view of an alternative suturing device having asingle needle-grasping clamp.

FIG. 16 is a side view schematically illustrating a suturing devicesimilar to that of FIG. 12A in which an extension of the body betweenthe clamps and proximal housing has been manually bent for a particularpatient, in which the clamps are actuatable through the bent extension,and which is being grasped by a hand of a surgeon.

FIGS. 17A-D schematically illustrate an alternative suture device havinga plastically bendable extension and a laterally flexible shaft so as tofacilitate custom bending or configuring of the suture device by theuser for a particular surgery.

FIGS. 18A-18C illustrate a perspective view, a side view, and anexploded view, respectively, of an alternative embodiment of a suturingdevice similar to that of FIGS. 11A and 11B, in which the clamps areincluded in a rapidly detachable clamp unit, and in which the clamp unitis latched to the drive unit by sliding a cover of the drive unitdistally.

FIGS. 19A-19C are perspective views showing a suture system a clamp unithaving extensions which angle outwardly distally of the drive unit so asto accommodate a large needle, the angled clamp unit, and the driveunit, respectively.

FIGS. 20A-20C schematically illustrate actuation of a clamp unit havingangled extensions.

FIGS. 21A and 21B illustrate a clamp unit having an elongate extensionfor use in minimally invasive surgery, and the elongate clamp unitattached to a drive unit, respectively.

FIG. 22 illustrates differing clamp units and its indicia of anassociated needle size or type.

FIGS. 23A and 23B illustrate alternative embodiments of suture apparatushaving a single clamp and a shaft with an axial bend for access toremote tissue sites.

FIGS. 24A and B are partial cross-sectional views schematicallyillustrating components of a suture apparatus having a clamp articulatedby axial movement of a flexible tension member with a bent tubularextension, and by axial movement of a series of axial elements withjoints therebetween, respectively.

FIG. 24C schematically illustrates an alternative series of axialelements with joints therebetween for articulation on a clamp through abent extension.

FIG. 25 illustrates an alternative clamp and adjacent extension of asuture apparatus.

FIG. 26 schematically illustrates an embodiment of a linkage forarticulating a clamp via a flexible tension member.

FIGS. 27A and 27B illustrate use of a suturing device having the clampof FIG. 25, in which the clamp is rotatable relative to an axis of theextension so as to allow the user to vary an angle of the needle aboutthe extension axis prior to suturing.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is generally directed to improved medical suturingdevices, systems, and methods. Exemplary embodiments of the inventionprovide improved suturing devices and methods for suturing tissues thatcan significantly increase the speed and ease of suturing, particularlywhen suturing of long incisions or where large numbers of stitches areto be deployed.

The invention should find a wide variety of applications for stitchinganatomical tissues in both humans and animals. Along with endoscopicoperations (for example, in laparoscopy, though generally encompassingoperations with or without trocar access) these structures and methodsmay find use in other areas of surgery where tissues are to be stitched,providing particular advantages for stitching of large incisions byincreasing the ease and speed with which each individual stitch may beplaced, as well as facilitating and expediting the formation of knots inthe suture. The suturing devices and associated methods described hereinmay, for example, be used suture a wide variety of strata of anatomicaltissues, including (but not limited to) subcutaneous layers, fascia, theouter skin, various organs (including the uterus), and the like. Whileexemplary embodiments are set forth below, these suturing devices andmethods may be applicable to a wide variety of suturing operations,including open surgery, large and small cavity procedures, endoscopicprocedures (with or without trocar access), microsurgeries (includingfor suturing of veins, arteries, and the like), and many specializedsurgeries. Embodiments of these devices and methods may be particularlyuseful for surgeries involving long incisions, including plasticsurgeries. A wide variety of blood vessels, including both veins andarteries, may also be stitched using the techniques described herein,for formation of anastamoses and the like. Along with increasing thespeed and/or ease of forming surgical suture stitches, embodiments ofthe invention will often maintain the control a doctor has over theplacement of the sutures by maintaining a fixed relationship between themovements of the doctor's hand and the insertion and withdrawal of thesuturing needle. Hence, among the procedures which may benefit from theinvention are subcuticular peritoneum, fascia closure, and skin closure,and the like. Exemplary uses may include therapies in the fields ofobstetrics and gynecological surgeries (including cesarean sections,hysterectomies, and the like), cosmetic surgeries, ophthalmic surgeries,and the like.

While embodiments of the invention may include (or be used within) apowered or automated system, optionally making use of electromechanicalpower, hydraulic power, or the like (for example, with some embodimentsbeing included within a robotic system), other embodiments may beconfigured for manual manipulation by one or more hands of a surgeon,often without having to resort to complex subsystems or external power.

Many embodiments of the devices described herein will be sterilizable soas to allow repeated use. Sterilization may be effected using autoclavetechniques, chemical sterilization, irradiation, or the like, with mostor all of the structures of the suturing device being formed ofmaterials suitable for repeated sterilization (such as stainless steel,other metals and alloys, and the like). In general, the suturing devicemay comprise one or more plastics and/or metals common to surgicaldevices. Although specialized or proprietary suturing needles may beemployed in some embodiments (for example, needles having flat grippingsurfaces so as to maintain an alignment between the needle and anassociated clamp), many embodiments of the suturing device will besuitable for use with standard off-the-shelf suture needles such asthose packaged with any of a wide variety of permanent or resorbablesuture materials in a hermetically sealed package. In fact, theinvention may find some of its most immediate applications forfacilitating surgical procedures performed manually in Third Worldcountries, allowing physicians to treat a larger number of patients withgreater ease than can be done using standard suturing techniques, butwithout the cost or complexity of recently-proposed automated suturingsystems.

Referring now to FIG. 1, an exemplary suturing system 100 generallyincludes a suturing device 102 and a needle 1. Needle 1 generally has aproximal end 104 and a distal end 106, with at least the distal endbeing sharpened to facilitate insertion of the needle distally into andthrough tissues. Surgical needles are often formed with a curving shapebetween the proximal and distal ends, and are often packaged with asuture extending from proximal end 104, with the needle sometimes beingreferred to as an acus.

Suturing device 102 generally has a body 112 having a proximal end 108and a distal end 110. A pair of clamps 3 are disposed near the distalend 110, while first and second handles 6, 8 are disposed near proximalend 108. Body 112 may include a proximal housing 7 and a distalextension 4. The distal extension may have a pair of channels, with eachchannel reciprocatably receiving a shaft 2 supporting an associatedclamp 3.

In this embodiment, clamps 3 arc mirror-symmetric, although they mayalternatively have differing shapes. Clamps 3 are generally offset so asto grip axially offset portions of needle 1, with one of the clampsgripping a more proximal portion of the needle and the other clampgripping a more distal portion of the needle. When handles 6, 8 are in aclose-handed configuration as illustrated in FIG. 1, only one of clamps3 will typically grip needle 1, the other clamp being retractedproximally away from the needle. Handles 6, 8 have openings forreceiving fingers of the surgeon's hand, and the surgeon will typicallyactuate the handles by opening them from the closed-handed configurationshown to an open-handed configuration 114. Starting with handles 6, 8 inthe closed (as shown in FIG. 1), when the handle is moved to open-handedconfiguration 114 and is then returned to the closed-handedconfiguration, the handle may be described as having completed anactuation cycle.

With each actuation cycle of handles 6, 8, the clamp 3 supporting needle1 is alternated so that a needle initially supported by grasping theneedle in first clamp along a proximal portion of the needle will, whenhandles 6,8 are in open-handed configuration 114, instead be supportedby the second clamp along a more distal portion of the needle. Ashandles 6,8 move back to the closed-handed configuration to complete thecycle, the clamps again alternate, so that closing of the handle resultsin extension of the proximal clamp, gripping of needle 1 with thatproximal clamp, release of the needle from the distal clamp, andretraction of the distal clamp. The position of needle 1 relative tobody 112 may remain substantially fixed throughout the handle actuationcycle, although the shafts may move axially slightly as the needle goesfrom being held by one clamp, to both clamps, and then to the otherclamp, with this movement of the needle being less than a length of theneedle.

Referring now to FIGS. 1 and 2, handles 6, 8 are pivotally attached tohousing 7 of body 112. Housing 7 generally includes at least one lid 9(the top lid shown removed in FIG. 2), with the proximal housingpreferably including opposed first and second lids 9 on opposed majorsurfaces of the body. Lids 9 and the other structures of housing 7generally enclose a drive linkage 116 coupling handles 6, 8 to clamps 3.In the embodiment of FIGS. 1-9, drive linkage 116 generally includes adrive wheel 11 and two driven wheels 10 and 12. The driven wheels 10 and12 are mirror-symmetric and joined by tie rods 14 and 21 to clamps 3.

Referring now to FIGS. 1-3, driven wheel 10 has a thrust surface 24,while driven wheel 12 has a stop surface 23 and an incline 22. Thedriving wheel is supported so as to rotate about an axle 20, the drivingwheel also having a lug 13. The driving wheel 11 is coupled to handles6, 8 by tics 18 and 19, so that actuation of the handles relative to thebody 7 induces rotation of driving wheel 11 about the axle. The drivenwheels 10, 12 rotate coaxially with driven wheel 11.

Lug 13 generally comprises an alternatable configuration drivingelement. Lug 13 either drivingly couples driving wheel 11 with drivenwheel 10, or with driven wheel 12, depending on the configuration of lug13 at the time. More specifically, when lug 13 is disposed above a guide15 as shown in FIG. 2, the lug drivingly couples the driving wheel 11with the upper driven wheel 10. When lug 13 is disposed below guide 15,the lug drivingly engages driven wheel 12, and is disengaged from drivenwheel 10. A reset or release input button 16 interacts with guide 15 anda spring-loaded positioning arm 17 so as to allow both clamps 3 torelease needle 1.

As can be understood with reference to FIGS. 1-4, each clamp 3 isconnected by an associated shaft 2 to the remaining components of drivelinkage 116. Shafts 2 each include a lengthwise slot 118 (see FIG. 4),which allows the shaft to move within the channels of body extension 4.Guiding pins 32 ride in slots 118, and the guiding pins 32 are alsofixed in extensions 4 within openings 5.

Moving wedges 31 within shafts 2 also have lengthwise slots 118 forreceiving guiding pins 32. The wedge surfaces of moving wedges 32 engagecorresponding surfaces of working jaws 25, with the working jaws formingthe open and closable structure of clamps 3. More specifically, distalmovement of moving wedge 31 against a corresponding surface of workingjaws 25 closes clamps 3, the working jaws being attached to a distalclevis of shaft 2 by axle 27. A spring ring 30 biases working jaws 25 toan open configuration, allowing them to move around and capture needle 1before the working jaws are forced shut by the moving wedges.

Working jaws 25 may have a variety of surfaces for holding needle 1, theclamps preferably holding the needle so that movement of the needlerelative to suturing device 100 is inhibited during stitching. Thesurfaces of working jaws 25 may be hardened by deposition of diamond ora diamond-like carbon, or inserts 26 of a material harder than that ofworking jaws 25 may be provided. Optionally, working jaws 25 may havehard-surfaced inserts comprising tungsten and/or cobalt, with theinserts optionally being fabricated using powder sintering or the like.

A return spring 28 extends between pin 28 in working jaws 25 and theguiding pin 32, with the return spring partially fixed within a lumen ofmoving wedge 31. A spring 34 in the proximal portion of moving wedge 31is held by a plug 37, with the distal end of spring 34 interacting withshaft 2 via thrust ring 33. Spring 34 can bring the moving wedge 31 intoa position suitable for releasing the working jaws. A compensationspring 36 pressed against plug 37 writes on a rod 35 of a pusher 42 soas to maintain a desired axial force. Pusher 42 has an insert 40, whichis connected with the pusher 42 by pin 39 and lug 38. The lug rotatesabout axle 41.

When handles 6 and 8 are moved apart to an open-handed configuration114, a retracted clamp 3 and its associated shaft 2 moves from within achannel of body extension 4. While retracted, the moving wedge 31 isbiased by spring 34 away from working jaws 25, so that spring ring 30 isfree to open the clamp to allow it to extend around needle 1. Extensionof compensating spring 34 may be at its greatest point while theassociated clamp 3 is retracted, and insert 40 extends from pusher 42with lug 38 in the insert.

As handles 6 and 8 are brought together, driving wheel 11 is turned byconnector ties 18, 19. Lug 38 interacts with thrust surface 24 of drivenwheel 10 and moves the driven wheel 10 in rotation. The motion of drivenwheel 10 is transferred by tie rod 14 so as to move insert 40 axiallyalong body extension 4. The insert, in turn, moves the pusher 42 alongbody extension 4, the relative position of the insert 40 and pusher 42being maintained by an inner surface of shaft 2 interacting with plug 30so as to inhibit rotation of the plug about axle 41. Pusher 42 pressesspring 34 and compensation spring 32, and via plug 37 and thrust ring33, moves shaft 2. The movement of shaft 2 overcomes spring 29 andextends the shaft from the channel of body extension 4.

During distal movement of pusher 42, spring 34 and compensating spring36 are sufficiently stiff so as to inhibit elongation, as their springcoefficients are significantly higher than that of return spring 29.However, engagement between an end of slot 118 in shaft 2 and guidingpin 32 eventually inhibits further distal movement of the shaft.

Once shaft 2 has stopped its distal movement (due to engagement oflengthwise slot 118 with guiding pin 32), spring 34 begins to contract,its rigidity being lower than that of compensating spring 26. As aresult, moving wedge 31 begins to extend distally relative to workingjaws 25, the corresponding surfaces of the wedge and working jawssliding against each other so as to move the proximal ends of theworking jaws apart and bringing the distal needle gripping inserts 26 ofworking jaws 25 together so as to grasp needle 1. As spring 34contracts, contraction of compensation spring 36 also begins and theinsert 40 moves. When lug 38 extends into and/or engages window 2a ofshaft 2, pusher 42 engages a surface of body extension 4 or proximalhousing 7, and axial movement of the pusher stops. Insert 40 continuesmoving, so that lug 38 rotates around axle 41. The lug interacts with anedge of shaft 2 and, overcoming compensation spring 36, starts to drawshaft 2 and its contents into body extension 4.

The clamping force on needle 1 by clamps 3 may be determined by thespring characteristics of compensating spring 36 so as to remain withina desired range. Advantageously, the clamping force imposed by suturingdevice 100 on needle 1 may correspond to forces applied by standardneedle holders. Thrust surface 23 of driven wheel 12 approaches a toothof spring-loaded fixing arm 17, and overcoming the spring, the thrustsurface passes under the tooth, releasing the tooth so that the toothand thrust surface are positioned for neutral engagement. After thethrust surface 23 of the driven wheel 12 passes beyond the tooth ofspring loaded fixing arm 17, engagement of the thrust surface and toothinhibit the return of the driving linkage 116 to its priorconfiguration, thereby inhibiting the release of needle 1 from theclosed working jaws 25 so that the needle is not dropped.

As handles 6, 8 continue to move toward the open-handed configuration ofthe handle actuation cycle, movement of driven wheel 12 is inhibited byspring-loaded fixing arm 17. Driving wheel 11 nonetheless turns, and isreset. More specifically, incline 22 of driven wheel 12 moves lug 13from a configuration above guide 15 to a configuration in which the lugis disposed under the guide. Hence, when handles 6, 8 continue to move,here towards a closed-handed configuration, the lug 13 will interactwith thrust surface 24 of the driven wheel 10. The description aboveregarding driven wheel 12 is thus repeated but with driven wheel 10instead. When moving under the spring-loaded fixing arm 17, the thrustsurface 23 of driven wheel 12 lifts the spring-loaded fixing arm 17 andreleases driven wheel 10.

By action of spring 34, moving wedge 31 is retracted proximally frombetween the proximal ends of working jaws 25, so that the proximal endsof the working jaws are brought together by spring-loaded ring 30.Distal ends of working jaws 25 thereby move apart and the needle isreleased.

Each repeated opening and closing actuating cycle of handles 6, 8alternates the needle between being held by one, and then the other ofclamps 3, and often back to the first clamp. In other embodiments, eachhandle actuation cycle effects transfer of the needle from one clamp tothe other, with the needle returning to be held solely by the firstclamp only with a second handle actuation cycle. Regardless, during eachcycle each retracted clamp is preferably extended around an associatedportion of needle 1 and is closed before the previously extended clampopens, so that the needle is held continuously by at least one of clamps3 throughout the handle actuation cycle.

If it is desired to release needle 1 from suturing device 112 at anytime during, before, or after a handle actuation cycle, release can beeffected by pressing on release input button 16. Pressing on button 16causes spring-loaded fixing arm 17 to lift away from driven wheels 10and 12, thereby resetting the clamps in their proximal openedconfiguration.

Referring now to FIGS. 5-9, the use of suturing device 102 for suturingan incision I in tissue T can be understood. Initially, handles 6, 8(see FIG. 1) are in a closed-handed configuration and the handles aregrasped by a hand of a surgeon. Needle 1 is supported by a first clamp 3a, with the first clamp grasping a proximal portion of the needleadjacent a suture S. The second clamp 3 b is retracted proximally awayfrom needle 1, so that a distal portion of the needle is free andexposed, as illustrated in FIG. 5.

As can be understood with reference to FIG. 6, the surgeon manuallymoves suturing device 102 by manipulating handles 6, 8 so as to insert adistal portion of suturing needle 1 through tissue T. Advantageously,body 112 and linkage 116 (see FIG. 2) of suturing device 102 inhibitsrelative movement of needle 1 relative to the body and handles 6, 8 ofthe suturing device while the handles are closed. This allows thesurgeon to precisely control movement of the needle 1 as it is insertedthrough the tissue, in a manner analogous to manual manipulation of theneedle using a standard needle grasper or forceps. As can be understoodwith reference to FIGS. 6 and 7, once the distal portion of needle 1extends sufficiently through the tissue, handles 6, 8 can be cycledthrough at least a portion of their actuation cycle. Through the linkage116, second clamp 3 b is extended distally from body 112 of suturingdevice 102, grasping the distal portion of needle 1. The first clamp 3 athen releases needle 1 and is withdrawn proximally from around theneedle, as illustrated in FIG. 8.

As can be understood with reference to FIGS. 8 and 9, once needle 1 isheld by second clamp 3 b, the surgeon can again manipulate the needle bymoving handles 6, 8. In some embodiments, the surgeon can grasp thehandles in an open-handed configuration while pulling the needle freefrom the tissue, while in other embodiments the needle will be pulledafter the handle has returned to the closed-handed configuration.Regardless, the surgeon uses the handles, body, and clamp 3 b to pullthe proximal portion of needle 1 through tissue T, thereby leavingsuture S inserted across incision I.

Prior to initiating a second stitch, the surgeon can cycle handles 6, 8by closing the handles with his/her hand, or by opening and closing thehandles through a full actuation cycle. This results in grasping ofneedle 1 by first clamp 3 a and release of the needle by second clamp 3b, exposing the distal portion of the needle and displacing the secondclamp from the needle so that the needle is ready to again insertthrough tissue T, as can be understood with reference to FIG. 5. Theprocess can then be repeated without ever having to completely releaseneedle 1, and by simply actuation of handles 6, 8 after insertion of thedistal portion of the needle through the tissue and again after eachpulling of the needle free. The process is repeated to form as manystitches as is desired. Analogous insertion of the distal portion of theneedle through loops of suture, actuation of the handle, and pulling theneedle free can be used to quickly and easily form knots.

As can be understood from the illustrations in FIGS. 5-9, and as may beindicated by the detailed description above of the articulation of thedrive linkage, shafts 2 extending distally from body 112 to clamps 3 a,3 b may move slightly during the handle actuation cycle, for example,with the shaft supporting the clamp initially holding needlel retractingslightly into body 112 as the other shaft extends. Nonetheless, eachclamp holds the needle at a fixed location while the surgeon holds thehandles 6, 8 in the closed configuration and inserts or withdraws theneedle into or from the tissue.

Referring now to FIG. 10, a wide variety of alternative linkagemechanisms, clamp structures, housing, handles, and the like may beemployed, as more fully described in US Patent Publication No.2007/0060931. For example, as seen in FIG. 10, an alternative suturingdevice 130 may include clamps 43, 44 which both retract proximally androtate away from needle when not used to hold the needle.

Referring now to FIGS. 11A and 11B, an alternative suturing devicesystem 202 may include many functional components which are similar tothose described above, but can generally be separated into a reusabledrive unit 204 and a disposable clamp unit 206. A releasable coupler 208releasably couples clamp unit 206 to the drive unit 204. The exemplarycoupler includes an interface that provides rigid coupling betweenextensions 210 of the clamp unit 206 and proximal housing 212 of driveunit 204, and also provides moving engagement surfaces between theshafts of the clamp unit and axially moving elements of the drivelinkage. While the exemplary releasable coupler 208 includes axialpositioning surfaces (in the form of a pin of drive unit 204 andcorresponding aperture of clamp unit 206) and a releasable latch toavoid inadvertent decoupling, a wide variety of alternative releasablecouplers might also be employed. The exemplary clamp unit includes twoclamps. In some embodiments, each clamp may be individually attached toa drive unit 204. Regardless, allowing the clamps to be detached fromthe drive unit can avoid any need for making the clamps sterilizable,decreasing overall costs of the suturing system and helping to ensurethat cross-contamination between patients is inhibited. A plurality ofclamp units 206 will often be used with each drive unit 204, with eachclamp being used for a single patient and then being disposed of.

Referring still to FIGS. 11A and 11B, a variety of alternative latchmechanisms may allow quick attachment, removal, and/or replacement ofthe clamp unit 206 from the proximal portion 204 of device 202. Forexample, rather than a hinged housing portion cooperating with a pin asillustrated, a slidable housing portion may slide distally over theclamp unit interface, and optionally over some or all of the pin. Avariety of different clamp units 210 may also be provided, with theclamp units optionally having different clamp geometries to accommodatedifferent needle sizes, such as by having different offsets between thejaws when the clamps are in the closed configuration to accommodatedifferent needle thicknesses, different separation distances and/orangular offsets between the pair of clamps to accommodate differentneedle lengths, radii of curvature, or needle configurations, and/or thelike. Similarly, a plurality of different clamp units may be providedwith different body extension lengths, bend angles, or thicknesses,and/or the portion of the linkage disposed within the clamp unit may beconfigured to apply a different clamping pressure to the needles (suchas by using different wedge or jaw geometry, using different springs tourge the jaws toward the closed configuration, or the like), providing asuture system that allows the user to flexibly and selectably configurethe suture device for a particular surgery.

A still further exemplary suturing device embodiment 220 can be seen inside and cross-sectional top views in FIGS. 12A and 12B. An elongateextension 222 coupling proximal housing 224 to clamps 226 may facilitateuse of suturing device 220 in endoscopic surgery (with or without trocaraccess) or the like. In this embodiment, actuation of drive linkage 228is generally effected by movement of a single articulatable handle 230relative to a grasping base 232 that is affixed to proximal housing 224.By allowing the surgeon to grasp a structure that remains rigidlyaffixed relative to the suturing device body with one portion of thehand, and articulate handle 230 with the fingers of that hand, theoverall position of suturing device 220 (and clamps 226, along with anyneedle supported therein) can be accurately maintained. As with theother embodiments described herein, a release 233 will often be providedthat, when actuated, releases a needle from both clamps and sets the twoclamps in a needle-receiving configuration.

The components and use of drive linkage 228 of suturing device 220 canbe understood with reference to FIG. 13 and FIGS. 13A-13M. As generallydescribed above, drive linkage 228 includes an alternatable driveelement 230 for alternating the driving of first one and then the otherof the two clamps. Additionally, drive mechanism 228 includes analternating latch or anchor 232 for inhibiting axial movement of theclamp that is not currently being driven. Drive linkage 228 furthermakes use of a channel casing 234 in which a movable tubular shaft 236slides along an axis 238. First and second pushers 240, 242 and a conewith a rod 244 are disposed along axis 238, while a striker 246 and astop pin with a spring 248 are disposed off of axis 238.

Reviewing the sequence of actuation of these components schematically,FIGS. 13A shows the components of drive linkage 228 at a beginningconfiguration (such as after actuation of the release), with both clamps226 in a configuration that is open and ready to receive a needle. InFIG. 13B, alternatable drive element 230 drives a first shaft 236distally along its axis till the shaft engages pin 248. Needle 250 isdisposed within the clamp, with the alternatable drive element 230continuing to move axially with movement of the handle.

In FIG. 13C, continuing movement of drive element 230 has produced axialmovement of pin 248 so as to compress its spring, so that the pin stopsmoving axially. As a result, continuing movement of drive element 230does not produce additional movement of shaft 236, but instead causesthe cone with its rod 244 to move within the shaft 236 till it reachesits distal position, as shown in FIG. 13D.

Additional movement by drive element 230 results in axial movement ofpushers 240, 242, causing the striker 246 to move into alignment with awindow in the shaft 236, and thus allowing the striker to engage andreposition latch 232. As the reconfigured latch 232 inhibits proximalmovement of shaft 236, the handle may be returned (often to its extendedposition, as can be understood with reference to FIG. 13F) withoutmovement of shaft 236.

Once the handle returns to its starting or extended position, needle 250may be inserted into and through the tissue. Returning of the handlealso reconfigures alternatable drive element 230 to engage the other,previously non-driven clamp actuation components, with the other shaft236 again moving distally along its axis due to movement of the handleto engage and compress pin 248 (as seen in FIGS. 13H and 13I), inducingaxial movement of the cone and rod 244 and allowing the associatedstriker to again reconfigure the alternatable latch 232 (see FIGS. 13Jand 13K). Reconfiguring the latch allows the extended, non-driven clamp226 to retract proximally to the configuration shown in FIG. 13L underthe influence of its proximal return spring, this retraction optionallyoccurring quite quickly. The handle may now again be released, with thereconfigurable drive element 230 again being reset to alternate thedriven and latched clamps, as shown in FIG. 13M.

Structures and methods which inhibit gradual displacement of needle 250relative to suturing device 220 during repeated cycling of drive linkage228 can be understood with reference to FIGS. 13I and 13K. As each clamp226 is extended to grasp needle 250, the clamp advances distallyslightly beyond the eventual location at which the clamp will hold theneedle for suturing. This stresses and/or displaces the needle slightly,and the clamp then grasps the needle at the extended location. Theextended location will typically be less than 20 diameters of the needlepast the other clamp, typically being a few needle diameters distal ofthe other clamp (smaller needles generally employing smallerstress-inducing distances). The grasping clamp that is to retain needle250 is retracted slightly to the grasping location and the other clampis opened, so that needle 250 is positioned for the next cycle, i.e., sothat the other clamp will again stress the needle before it is grasped.This slight alternating overshoot during grasping of the needle helpsmaintain the needle near the proximal end of the grasping jaws duringcycling. The needle may also be manually pre-angled by the surgeon,either proximally or distally, to facilitate proximal or distalsuturing. For example, the distal tip of the needle may extend or angledistally of the grasping clamps, rather than the needle being disposedperpendicular relative to the axes of the shafts. Cycling of drivelinkage 228 will largely reproduce and maintain the grasping angle asthe clamps alternatingly grasp the needle, with some gradual trendtoward a perpendicular needle induced by the alternating overshootduring large numbers of actuator linkage cycles (for example, withmovement of the distal portion of the needle proximally along the jawsby a few needle diameters or less with each cycle). Hard metal insertswith small protrusions or teeth along the grasping jaw surface may alsobe beneficial to limit inadvertent movement of the needle relative tothe jaws.

Referring now to FIGS. 14A-14C, a wide variety of alternative suturingdevice clamping arrangements may also be employed. An axially concentricsuturing device 260 is particularly well suited for use with a ski jumpneedle 262. Such needles may comprise a proximal straight section and adistal curving section, and may be commercially available from a numberof suppliers with suture affixed thereto (not shown). A proximal clamp264 and distal clamp 266 have clamping jaw members which separate androtate away from needle 262 to allow the needle to be inserted intotissue (in the configuration of FIG. 14A). The drive system may transferthe needle between the two clamps (FIG. 14B), and allow the needle to bepulled distally free of the tissue (in the configuration of FIG. 14C),with the clamps opening and closing with the cycling of a handle usingdrive elements that may be similar to, analogous to, or quite differentthan at least some of the drive components described above.

Referring now to FIG. 15, an alternative suturing device 270 may makeuse of many of the drive components described above, but may include asingle clamp 272. Rather than passing a needle back and forth betweentwo clamps, suturing device 270 may be used in a manner analogous tostandard needle drivers, and may be particularly well suited for use inthe endoscopic or other minimally invasive surgeries, with or withouttrocar access.

FIG. 16 schematically illustrates a suturing device 280 similar to thatof FIGS. 12A and 12B, with extension 282 between clamps 284 and proximalbody housing 286 here having a bend 288. While such suturing devices mayoptionally be sold in a pre-bent configuration, bend 288 mayalternatively be imposed by a surgeon, with the surgeon manually (oroptionally, with the assistance of one or more tools) bending theextension (or another structure supporting the clamps) to a desiredconfiguration for use in a surgical procedure on a particular patient.Extension 282 may be formed of a material (typically comprising a metalor polymer) which can withstand bend 288 while maintaining structuralintegrity of the suturing device, and the drive components which movewithin bend 288 (such as the axially movable shaft, rod with a cone, orthe like) may be formed of a material (or having a configuration) whichcan accommodate lateral deflection within the bent tubular extensionduring the actuation, such as by forming drive components of a suitablepolymer, making use of at least a portion of the drive components whichare formed as a helical coil, including thin, flexible sheet metalcomponents, or the like. In general, reconfiguring the drive componentsor support structures to employ bent sheet metal parts may also helpreduce manufacturing costs, and the like. Hence, the shaft may (forexample) comprise a sheet metal structure with end tabs having openingsto receive components therein, and/or the like. The positive control orpositioning of clamps 284 which can be available using a grasping basethat's originally affixed to the body housing 286 when suturing device280 is held by a hand H of a surgeon can also be understood withreference to FIG. 16.

Referring now to FIG. 17A-D, another alternative suturing device 402 hasa housing with an extension extending along an axis 406 from a proximalhandle 408 to a distal clamp 410. A linkage mechanism 412 transmitsmotion from handle 408 to clamp 410, via axial movement of a shaft 414,the shaft here being formed as an axial series of ball elements 416.Each ball element may, for example comprise a spherical structure, withor without an indentation to receive an adjacent ball element and allowsliding motion therebetween. Regardless, the shaft is stiff incompression to allow the linkage to push a wedge between slidingsurfaces of the jaw structure, as can be understood from the descriptionabove and the side cross-sectional illustration of FIG. 17C. A top viewof the clamp 410 is seen in FIG. 17B.

Extension 404 is plastically bendable, allowing the user to impose acustom bend on axis 406. The metal or other plastically bendablematerial of the extension will, when bending with shaft 414 therein,avoid kinking or collapsing so as to interfere with articulation oflinkage 412. The user will grasp and articulate the handle with thefingers and the thumb of the hand, and a simple ratchet 422 (see FIGS.17A and 17D) can releasably maintain the clamp in the graspingconfiguration.

Suturing devices having bendable or pre-bent extensions may find use ina wide range of open and minimally invasive surgical procedures,including endoscopic procedures (with or without trocar access),therapies of the ear, nose, and throat (ENT procedures), particularlyfor oral surgery and the like. Bendable or pre-bent devices andstructures may be combined with suturing devices and systems describedabove, including those having a plurality of differing alternative clampunits to allow configuration of the suturing device for a particulartherapy or patient, including clamp units having single clamps, multipleclamps of a similar type, multiple clamps of different types, and thelike. Other capabilities may also be included, such as including a lightcable or waveguide supported by and extending along the extension tohelp illuminate the workspace, including aspiration and/or irrigationlumens that extend axially along the extension, or the like. Hence awide variety of alternative devices, systems, and methods may beemployed.

Referring now to FIGS. 18A-18C, an alternative embodiment of a suturingassembly 502 may include a drive unit 504 supporting a clamp unit 506via a quick-disconnect interface 508. As described and shown above inFIGS. 11A and 11B, a handle 510 of the drive unit may articulaterelative to a drive unit body 512 so as to articulate the clamps via alinkage, with a portion of the linkage being supported by the drive bodyand a portion being integrated into the clamp unit. Coupling of a shaftportion of the drive unit to a corresponding shaft portion of the clampunit (with the shaft of the linkage articulating the clamps as describedabove) may be facilitated, for example, by having springs which positionthe shaft portions of the clamp unit in preparation for engagement, byhaving axially engagement surfaces which laterally receive and axiallyposition the shaft portions relative to each other, and the like (as canbe seen in FIGS. 18A-18C, 24A, and 24B). An axial positioning feature(such as a laterally extending post or the like) and associatedreceptacle of the interface 508 can axially position a body of the clampunit relative to the drive unit body 512, with coupling of the interfacebeing maintained in the embodiment of FIG. 18A-18C by sliding a coverdistally 514 so as to laterally restrain the clamp unit.

As more fully described in patent application Ser. No. ______, filedconcurrently herewith and entitled “Replaceable Tip Suturing Devices,Systems, and Methods for Use with Differing Needles, a suturing systememploying many of the components of FIGS. 18A-18C can facilitatesuturing with any one or more of a variety of suture needle sizes and/ortypes. The needles may also each have a standard size or typeidentifier, exemplary needles comprising a CTX, a CT-1, a PS-2, and/orthe like, with the needle geometry (such as the needle length, anyangular arc defined by the needle, the radius of curvature of the arc,the thickness of the needle, and the like) varying with the needleidentifier. Each needle used with the system will have at least oneclamp unit associated therewith, with the clamp unit having a geometrysuitable for use with the associated needle geometry.

FIGS. 19A-19C illustrate an embodiment of a suture system 540 having aclamp unit 542 with separately movable extensions 544 a, 544 b, for eachclamp. In this embodiment, each extension 544 a, 544 b is supported by aclamp unit body 546 via a cam-and-follower arrangement 548, so that whenthe clamps are distally extended for grasping needle 522 a, they angleoutwardly away from each other (moving from the drive unit toward theneedle). This will facilitate grasping of different length needles withdifferent clamp separation distances while still using a common driveunit 550. Note that the angle need not be defined at all times by theclamps and each component of their associated support and actuationstructures, particularly when they are retracted proximally from theneedle.

Referring now to FIGS. 20A-20C, articulation of clamp unit 542 of FIGS.19A-19C is shown in an initial position with the clamp 570 grasping aCTX needle 574 in FIG. 20A. The extension structure supporting extendedclamp 570 angles distally outwardly, while the structure supporting theretracted clamp 572 is parallel to a midline of the system. As thesystem cycles, cam-and-follower arrangement 548 causes the extensionsupporting clamp 572 to also angle outwardly as you move distally alongthe extension, with the clamps extending along axes having an angle 576therebetween when both are grasping the needle 574 as seen in FIG. 20B.Clamp 572 then retracts and moves toward the mid-line to complete thealternating of the clamps, as seen in FIG. 20C.

FIGS. 21A and 21B show yet another alternative clamp unit 580 that maybe used with drive unit 550 of the clamp system of FIG. 19A, with clampunit 580 having an elongate extension body 584 extending between a driveunit interface 582 and the clamps. Such an extension body may beconfigured for endoscopic surgeries, such as by having a roundcross-sectional shape suitable for insertion through a trocar or otherminimally invasive access port structure or the like, optionally so asto maintain insufflation. Alternative embodiments may be used (and/orconfigured for use) without such access ports. Structures intended foruse through a trocar may have diameters which can be sealingly engagedby the trocar (such as by corresponding to the trocar seal diameter orbeing within the trocar seal size range) while allowing rotationaland/or axial movement about or along the axis of the trocar (such as byhaving a smooth cylindrical outer surface). Other embodiments that arenot intended for use with a trocar may, for example, have non-roundouter surface cross-sectional shapes, easily gripped outer surfaces, orthe like. Extensions of alternative lengths, cross-sectional sizes, andthe like may be provided so as to facilitate surgeries of differenttypes using the same drive unit. In other embodiments, at least aportion of the extension may be incorporated into a drive unit intendedfor minimally invasive surgeries. The extension may be plasticallybendable by the user prior to insertion, or may be pre-bent as suppliedto the user from the manufacturer or other supplier.

Alternative indicia of the associated needle is seen in the mountedclamp unit of FIG. 22. Such indicia may comprise a written indication ofor identifier for the associated needle, a color code associated withthe needle size, a proprietary needle code, name, or number, or thelike. A range of needle sizes, shapes, or types may be associated withthe indicia of a single clamp unit, or the indicia may be specific to aparticular needle geometry from a particular supplier. The indicia maybe embossed on the clamp unit, attached to the clamp unit as a sticker,painted on the clamp unit, or the like.

Referring now to FIGS. 23A and 23B, alternative embodiments of suturingdevices 600, 602 having extensions 604, 606 with bends 608, 610 can beseen. The handles may take any of a wide variety of forms, andinterfaces 612 may be defined between the clamps 614 and the drivebodies 616. At least one of the interfaces may be manually rotatableprior to suturing, such as by manually twisting the extension about theextension axis relative to the structure on the other side of theinterface. The interface may inhibit inadvertent rotation across theinterface using friction, a series of detents, a threaded lockingstructure, or the like. Optionally, axially displacing the structuresacross the interface (such as by pulling the extension distally awayfrom the body) may facilitate manual rotation, while the axial forcesimposed by the shaft or other axial movement transmitting structure(sometime referred to herein as the member) may help inhibit inadvertentrotation across the interface during suturing.

Referring now to FIGS. 17A, 23A, 23B, 24A, and 24B, a variety of axialmovement transmitting structures may be employed. As described withreference to FIG. 17A and also seen in FIG. 24B, axial movement maypropagate past the bend of the extension by compressing a series oflargely spherical compression elements. Such compressive transmission ofmovement may be particularly desirable where the bend angles are greatenough that alternative articulation members (such as a tension cable orthe like) would be subject to excessive length tolerance variability.For smaller bend angles, cables may be more beneficial.

As can be understood to these same figures, allows when one or moreinterface 612 the clamps to be rotated relative to the extension,linkage, and or other components of the device it may be advantageous toform the wedge that slidingly engages the sliding surfaces of the jawsas a cone 620 that is roughly coaxial with the adjacent structure of theextension. This can help make the interaction between the slidingsurfaces of the clamp and the wedge more insensitive to the orientationof the wedge about its axis. FIG. 24C schematically illustrates analternative series of elements that may be used to transmit movement incompression and/or tension through a tubular extension member having abend, in which ball-and-socket joints couple the adjacent elements. Theball-and-socket joints accommodate the bend by pivoting, and the ball ofone element may be restrained in the socket of an adjacent element by acompressive fit, by a cooperating protrusions and twist-lock channels,or the like.

As can also be understood with reference to FIGS. 24A and 24B, a springsystem may urge the jaws of the clamp open and/or shut. For example, oneor more ring spring 622 may be disposed in an associated groove 624 atleast partially encircling the jaws so as to urge the jaws open (via apivot between the groove and gripping surfaces). An axial spring 626,which may optionally extend from an associated ring spring 622 to atransverse tab 628 receivable through an aperture 630 of cone 622, maybe biased to resiliently urge the cone distally against the slidingsurfaces of the jaws. the actions of these springs may optionally opposeeach other. Depending on the relative strengths of the springs andwhether the actuation mechanism relies on compressive displacement ofthe member or tensile displacement of the member, the springs may,overall, either urge the jaws open or closed. In the embodiment of FIG.24B, the springs may effectively urge the jaws open so that they remainopen unless and until compressive displacement of the member (here thespherical elements) forces the jaws closed with a desired graspingforce. In contrast, in the embodiment of the FIG. 24A, while the ringsprings 622 urge the jaws open, the axial spring 626 is sufficientlystrong that, overall, the springs urge the jaws closed with a desiredneedle gripping force. Of course, when tensile movement by cable 632relative to extension 634 overcomes the spring force and moves cone 620proximally, the jaws can be opened when desired. Such an arrangement, inwhich the spring system imposes a needle gripping force between thegripping surfaces (and hence between the clamp and the needle), maypromote repeatable gripping performance each time the linkage is cycled.

Along with clamps having gripping surfaces that move laterally relativeto the extension axis, one or more of the gripping surfaces mayalternatively move axially. As seen in FIG. 25, needle 640 may be heldbetween opposed gripping surfaces 642, 644 by moving at least one of thegripping surfaces axially. Articulation of such a clamp may be effectedrelatively directly by axially coupling movement of a compression ortension transmitting member to one of surfaces 642, 644, with thetension or compression optionally overcoming a biasing spring that urgesthe clamp either open or closed. As seen in FIG. 26, a relatively simplelinkage 650 may cycle tension cable 652 from body 654 by pivoting arotatable cable tensioner 656 when a handle 658 pivots toward the body.Tension in cable 652 may be released by actuation of a ratchet 660.

Referring now to FIGS. 27A and 27B, rotation of clamp 650 relative toextension 652 and/or body 654 allows needle 656 to selectably extendhorizontally across an axis 658 of extension 652 (as shown in FIG. 27A)for suturing of a first tissue. When suturing of another tissue makes avertical orientation of needle 656 relative to the suturing device (asshown in FIG. 27B) desirable, the clamp may be rotated so as toaccommodate.

While exemplary embodiments of the invention have been described indetail, by way of example and for clarity of understanding, a variety ofmodifications, changes, and adaptations will be obvious to those ofskill in the art. For example, along with the exemplary drive linkagesdescribed herein, still further drive linkages may be provided,including those making use of cables and pulleys, worm gears, and thelike. Hence, the scope of the present invention is limited solely by theappended claims.

1-23. (canceled)
 24. A suturing method comprising: grasping a needlewith a clamp; supporting the clamp with an extension, the extensionhaving an axis with a bend in the axis; inserting the needle into atissue region by moving a body supporting the extension so that theneedle moves in correlation with the body; articulating the clamp bymoving a laterally flexible member axially relative to the extension,the member being axially inelastic.
 25. The suturing method of claim 24,wherein a distal end of the needle is inserted through the tissue bymoving the needle in rigid correlation with the body, and wherein theneedle is pulled free from the tissue by moving the needle in rigidcorrelation with the body.
 26. (canceled)